Are you or a loved one living with HER2+ breast cancer?

If so, learn about HER2CLIMB, a study testing the effects of an investigational medication in combination with standard treatments in patients with locally advanced or metastatic HER2+ breast cancer. You may be able to participate in the HER2CLIMB study even if you have brain metastases.

DO I QUALIFY?

About the HER2CLIMB Study

The HER2CLIMB study is testing the safety and efficacy of tucatinib (ONT-380), an investigational medication. Tucatinib is designed specifically to target and inhibit the growth of HER2+ cancer cells. Select patients with metastatic HER2+ breast cancer, including those who have brain metastases, may be enrolled into this clinical trial. Tucatinib is an oral medication that can be taken at home.

By participating in the HER2CLIMB study, you may benefit by:

  • Taking an active role in your own healthcare
  • Gaining access to study-related care and currently approved treatments
  • Helping others by contributing to medical research and shaping the future of medical care

 

There are also risks involved in the HER2CLIMB study, including:

  • Possible side effects from study medication
  • This investigational medication may have little, if any, benefit
  • The study will require time for traveling to the study site and for office visits

 

Eligible participants in HER2CLIMB will receive standard, approved treatments. In addition, you may also receive the investigational medication tucatinib.

Common Questions About Clinical Trials

  • What is a Clinical Trial?

    A clinical trial is a research study that tests the safety and effectiveness of a new medicine or treatment in a population of volunteers. Every medical breakthrough goes through the clinical trial process. Therefore, participants like you play a very important role in advancing medicine for present and future generations.

  • Why participate in the HER2CLIMB Study?

    There are both benefits and risks associated with participation in any clinical study, including the HER2CLIMB Study. By participating in the HER2CLIMB Study, you may benefit by:

    • Playing an active role in your own healthcare
    • Gaining access to study-related care and currently approved treatments
    • Helping others by contributing to medical research and shaping the future of medical care

    There are also risks involved in the HER2CLIMB Study, including:

    • Possible side effects from study medication
    • This investigational medication may have little, if any, benefit
    • The study may require time for traveling to the study site and getting the treatment

  • What is an investigational medication?

    An investigational medication has been tested in the laboratory and the U.S. Food and Drug Administration (FDA) is allowing it to be tested in people. It is not approved for sale by the FDA or other government agencies. A clinical trial tests how well an investigational medication works and whether it is safe to use.

  • How does a clinical trial evaluating an investigational medication work?

    A clinical trial has a structured set of clinic visits, tests, and drug dosing schedule the patient must follow. Information about how you feel and how your cancer is reacting to the study treatment is collected.

  • How are my rights and safety protected as a patient during a clinical trial?

    Protecting the health and safety of people who take part in clinical trials is a high priority for clinical researchers throughout the entire study process. All clinical trials follow strict federal guidelines on how volunteers must be treated.

  • Can I leave a clinical trial before it ends?

    You have the right to leave a clinical trial at any time, for any reason. If you decide to leave a trial, talk to your doctor first. You’ll want to know how leaving the trial might affect your health and what other treatment options you have. By ending your participation in the clinical trial, you do not give up your right to receive care for your cancer.

  • How can I learn more about the investigational medication and this study?

    One of the study doctors will discuss the investigational medication with you and answer any questions you may have about the HER2CLIMB Study.

Am I Eligible for the HER2CLIMB Study?

To be eligible for the HER2CLIMB study you must have:

  • A diagnosis of locally advanced or metastatic HER2+ breast cancer
  • Already have received the following four common therapies for the treatment of breast cancer:
    • trastuzumab (Herceptin®)
    • pertuzumab (Perjeta®)
    • T-DM1 (Kadcyla®)

Eligible patients may or may not have brain metastases

Eligible participants in HER2CLIMB will receive standard, approved treatments. In addition, you may also receive the investigational medication tucatinib (ONT-380).

If you enroll in the HER2CLIMB study, you may receive reimbursement for approved travel expenses associated with participating in the study. Your cancer prognosis may or may not improve by taking part in the HER2CLIMB study.

How Can I Learn More About HER2CLIMB?

Start by using the map to find a study location near you. This will help you select the closest study site to your location.

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